VO Sarzhevskii, EA Demina, NE Mochkin, AA Spornik, AA Mamedova, EG Smirnova, AE Bannikova, AA Samoilova, VS Bogatyrev, VYa Melnichenko
NI Pirogov Russian National Medical Center of Surgery, 70 Nizhnyaya Pervomaiskaya str., Moscow, Russian Federation, 105203
For correspondence: Prof. Vladislav Olegovich Sarzhevskii, MD, PhD, 70 Nizhnyaya Pervomaiskaya str., Moscow, Russian Federation, 105203; Tel.: +7(495)603-72-17; e-mail: vladsar100@gmail.com
For citation: Sarzhevskii VO, Demina EA, Mochkin NE, et al. Checkpoint Inhibitors and Classical Hodgkin’s Lymphoma: Efficacy and Safety of Pembrolizumab in Relapsed/Refractory Tumor (Experience at the NI Pirogov Russian National Medical Center of Surgery). Clinical oncohematology. 2021;14(1):53–62. (In Russ).
DOI: 10.21320/2500-2139-2021-14-1-53-62
ABSTRACT
Background. Checkpoint inhibitors contribute to improving the treatment outcomes in patients with relapsed/refractory classical Hodgkin’s lymphoma (cHL). The paper describes the first generalized experience with pembrolizumab-inducing cHL immunotherapy in Russia. The hallmark of the study is a long follow-up period.
Aim. To retrospectively assess efficacy and safety of pembrolizumab-inducing immunotherapy of relapsed/refractory cHL.
Materials & Methods. The study enrolled 14 cHL patients: 3 men and 11 women aged 24–57 years (median 33 years). Pembrolizumab 200 mg or 2 mg/kg was intravenously administered every 3 weeks. Median pembrolizumab administration number was 27 (max. 52 administrations), median follow-up after immunotherapy onset was 31 months.
Results. Complete response (as best response) was achieved in 8 (57 %) patients, 3 (21 %) patients showed partial response (as best response). Overall objective response was 78 %. Median number of pembrolizumab administrations resulting in better responses to immunotherapy was 4, which corresponded to 3 months of treatment. Maximum number of pembrolizumab administrations before achieving best response was 32. Best response duration (the period from achieving it to disease progression/relapse or to the end-point of data collection in case of sustained response) varied from 3 to 56 months (median 15 months). Most common severe adverse events of grade 3–4 were pulmonary complications. Overall survival for 12, 24, and 36 months was 92.9 %, 85.7 %, and 85.7 %, respectively, and progression-free survival was 76.9 %, 59.3 %, and 37.1 %, respectively; median time before progression was 27.7 months.
Conclusion. The experience with pembrolizumab-inducing immunotherapy of relapsed/refractory cHL in Russia proves the efficacy and relative safety of this treatment approach. Due to long follow-up period a series of crucial practical immunotherapy-related issues were raised, which will need to be dealt with in future studies.
Keywords: сheckpoint inhibitors, immunotherapy, classical Hodgkin’s lymphoma, pembrolizumab.
Received: September 7, 2020
Accepted: December 2, 2020
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